Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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Why You Should Measure Comparability Debt Before Ever Starting A Study

When analytical capability and process understanding fail to keep pace with a drug candidate, the technical uncertainty creates debt that's difficult to pay down.

GUEST COLUMNISTS

AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.

PHARMA OUTSOURCING WHITE PAPERS

Why Biopharma Breakthroughs Aren't Moving The Market
Biopharma is innovating fast but falling short commercially. Reveal key ecosystem gaps and five strategic actions to help strengthen resilience, accelerate performance, and futureproof organizations.

Redefining Value In Biologics Outsourcing Partnerships
Biologics outsourcing is shifting to strategic partnerships focused on modality expertise, regulatory excellence, and integrated end-to-end capabilities.
Revolutionizing Lentiviral Vector Manufacturing For In Vivo, Ex Vivo CAR-T Therapies
Discover how scalable, cost-effective, and high-quality lentiviral vector manufacturing can accelerate both ex vivo and emerging in vivo CAR-T therapies.
The Key To Viral Vector Success
Establishing a robust and scalable viral vector process requires a multidisciplinary approach that incorporates expertise in foundational science, analytics, and biomanufacturing.
Tool Enzymes For Antibody-Drug Conjugate Development And Manufacturing
See how modern tool enzymes enable cleaner, more consistent ADC conjugation, sharper analytics, and a smoother path from research to clinical development — practical guidance for manufacturing.
Safely Scaling High Potency API Manufacturing
Scaling HPAPI production demands disciplined containment and exposure control. Integrated operating models help manage risk while enabling compliant, reliable scale‑up.